NCT03185026: PEPSUI

Psychoeducation for Suicidal Behavior

Recruiting now NA Last updated 9 August 2024

What this trial tests

NA trial testing Interventional group : PEPSUI psychoeducational program in Suicide, Attempted in 500 participants. Currently enrolling.

Timeline

6 September 2017

Primary endpoint
6 May 2026

6 May 2026

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	500
Start date	6 September 2017
Primary completion	6 May 2026
Estimated completion	6 May 2026
Sites	1 location across France

Drugs / interventions tested

• Interventional group : PEPSUI psychoeducational program
• Relaxation group

Conditions studied

• Suicide, Attempted — all drugs for Suicide, Attempted →
• Suicidal Behavior — all drugs for Suicidal Behavior →

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 65, any sex, with Suicide, Attempted or Suicidal Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aims of the recent World Health Organization report, highlighting that every 40 seconds a person dies from suicide somewhere in the world, are to increase awareness on the public health significance of suicide and make suicide prevention a greater priority within the global public health agenda. Across age groups, less than half of individuals at elevated suicide risk interface with some form of mental health services. Several barriers to help-seeking have been identified (maladaptive coping, lack of perceived need, beliefs about treatment effectiveness, fear of hospitalization or mistrust of providers, stigma...), which are key targets in knowledge-based interventions on suicide. Psychoeducational programs have shown effectiveness in prevention relapse for several mental disorders such as schizophrenia, bipolar disorder or recurrent depressive disorder, improving treatment adherence and self-confidence in coping with symptoms of the disease. They are highly recommended for addressing adherence problems in patients with serious and persistent mental illness. Only one team has published a study protocol for a controlled trial assessing a 10 group sessions psychoeducational program for prevention in patients having a suicide history, in a one-year follow-up. Interestingly, diagnosis-mixed group psychoeducation have shown superiority than an unspecific intervention add-on routine care, on the suicide prevention and compliance for severe psychiatric disorders. Those psychoeducational-specific elements are namely the interactive transfer of illness and treatment-related knowledge and management/coping - cognitive/behavioral - strategies, as defined by the National Institute for Health and Care Excellence)-Guidelines (NICE). Notably, as several psychiatric diagnoses are associated with suicidal behavior (SB), coping strategies have to target processes that overlap among these psychiatric disease, as well as suicidal vulnerability. Acceptance and Commitment Therapy (ACT), a "third wave" behavioral therapy, targets experiential avoidance and psychological flexibility, at the core of psychiatric disorders. Interestingly, in patients with a history of suicidal depression, training in mindfulness can help to weaken suicidal thinking associated with depressive symptoms , and thus reduce an important vulnerability for relapse to suicidal depression. ACT would also increase intrinsic motivation for daily life action (i.e. reasons for living and acting). Then, the functional analysis (matrix) used in ACT seems to be an useful tool to help patient in decision making, a neuropsychological factor impaired in suicidal patients. Finally, acceptance and commitment group therapy has suggested effectiveness in reducing intensity and frequency of suicidal thoughts, through improvement in acceptance, in high risk suicidal patients. As compared with ACT, Dialectical behavior therapy (DBT) teaches added distress tolerance in view of survive the crisis. DBT is the most validated therapy for borderline personality disorder, the mental disorder the most associated with SB . Notably, group skills training is the most effective component in DBT for preventing suicidal behavior in borderline patients with high suicidal risk. Furthermore, interventions based on positive psychology have suggested efficacy in reducing depressive symptoms and suicidal ideation. Notably, in a recent pilot study, positive psychology exercises delivered to suicidal inpatients were feasible and associated with short-term gains improvement in optimism and hopelessness. Finally, as altered social link and sense of belonging have been widely involved in SB, relationship skills are an interesting positive psychology area for suicide prevention program.

Psychoeducational program integrating knowledge as well the last innovating cognitive-behavioral coping strategies for SB is of major interest in suicide prevention.

Investigators developed the first French program of suicide psychoeducation called "PEPSUI". The aim of this innovating program is to teach patients the more recent knowledge about suicidal behaviour (SB) and effective treatments, through didactic and interactive sessions. Thus, the objective is to conduct the patients to become experts and actors of their disease, increasing adherence to treatment. Besides, the patients will experiment the last innovating psychological skills to cope with unpleasant emotions and thoughts (including suicidal thoughts), distress tolerance skills and crisis strategies, and identify personal purpose in life and learn positive psychological skills in order to anchor with meaningful and pleasant components in life. Thus, this program will include skills from ACT, DBT and positive psychology. Finally, this primary care research is about a program which aim at improving accessibility to mental health services, care adherence and continuity for suicidal patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychological therapies for people with borderline personality disorder.
   Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, et al · · 2020 · cited 208× · PMID 32368793 · DOI 10.1002/14651858.cd012955.pub2
2. Psychosocial interventions for self-harm in adults.
   Witt KG, Hetrick SE, Rajaram G, Hazell P, et al · · 2021 · cited 79× · PMID 33884617 · DOI 10.1002/14651858.cd013668.pub2